Senior Specialist, Quality Assurance for Quality Control

Job Title: Senior Specialist, Quality Assurance (QA) - Quality Control (QC) Instruments
Location: Southwest Boston
Onsite Requirements: Fully Onsite
Duration: 6+ months with potentially longer
Compensation Range: $45-$55/hr. (1099/C2C)
Life Sciences Consultancy is seeking a Senior Specialist, Quality Assurance (QA) to provide hands-on quality oversight for QC laboratory instrument/equipment activities in a regulated (GxP/GMP) environment. Candidates must have a bachelor's degree in a scientific/engineering discipline and 3-8 years of CQV/qualification experience in biotech/biopharma (or another regulated GMP industry). Candidates must have direct experience working within deviation management and change control processes and must be comfortable reviewing/approving validation/qualification documentation to support data integrity and inspection readiness. This role is fully onsite in the Greater Boston area (MA) and requires US work authorization (USC or GC only; no sponsorship) and the ability to pass standard background and reference checks.
Day-to-Day Responsibilities

• Review and approve QC equipment qualification/validation documentation (protocols, reports, periodic reviews)
• Review and approve QC method SOPs, forms, and data tables to support equipment readiness and data integrity
• Review QC logbooks and ensure documentation meets Good Documentation Practices
• Ensure QC personnel follow data integrity expectations and internal quality procedures
• Assess, classify, review, and approve deviations, change controls, CAPAs, work orders, and other quality system records tied to QC instrument/equipment activities
• Make quality decisions and provide guidance to maintain compliance with applicable regulations and internal requirements
• Execute work per approved procedures, SOPs, and work instructions
• Complete required training per assigned learning plan and requalification cadence
• Support audit/inspection readiness by ensuring documentation is complete, accurate, and readily retrievable

Required Skills & Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field
• 3-8 years of experience supporting CQV activities in biotech/biopharma or another regulated GMP environment
• Working knowledge of GxP expectations and regulated documentation practices
• Experience with deviation management and change control in a regulated environment
• Ability to review/approve documentation with strong attention to detail and compliance mindset
• USC or GC required (no sponsorship)
• Ability to pass standard background and reference checks

Preferred Skills & Qualifications

• Quality Assurance and/or Quality Control experience supporting laboratory instruments/equipment
• Familiarity with FDA, EU, and ICH guidelines and expectations
• Experience with analytical or microbiological QC testing environments (methods, validation, transfer concepts)
• Experience with risk management and digital quality system tools
• Experience with Kneat (or similar validation/qualification documentation software)
• Strong proficiency with Microsoft Office and comfort working with structured documentation sets